The human chorionic gonadotropin (HCG) weight loss protocol was originally developed by Dr. A. T. Simeons in the late 1940's. Dr. Simeons postulated that obesity was due to humans eating excessive calories for a prolonged period of time, causing the fat storage center of the brain to store the excess calories in a deep fat reserve. Dr. Simeons conducted research after World War II on concentration camp victims, and found that 85% became obese within six months of being released from captivity, even if they were not obese before. He postulated this was due to the fat storage center in the brain being open to its storage mode once the diet of these people contained more calories than the body was consuming in captivity.
Dr. Simeons theorized that the deep fat reserve was only broken down after prolonged severe calorie restriction, or after using HCG with calorie restriction. HCG, with calorie restriction, could result in a weight loss of up to 35 lbs. in six weeks, if the protocol was strictly followed. If the weight loss is maintained for approximately three to four weeks post HCG and diet, the weight loss is permanent in most people, due to a re-setting of the fat storage mechanism in the brain.
Dr. Simeons refined the protocol in Rome, Italy for 20 years after he started using the original protocol. Dr. Simeons postulated the use of low dose HCG (125 units intramuscularly) could enhance weight loss when a low calorie (500 calories per day) diet was followed. In his original work, and in all protocols since, the use of supplemental vitamins is discouraged, because it is felt the fat breakdown from the use of HCG releases vitamins and nutrients stored in the fat.
A double-blind study performed in 1973 by Asher and Harper supports the claims of Dr. Simeons. Asher, W L, Harper, H W. (1973) Effect of human chorionic gonadotrophin on weight loss, hunger, and feeling of well-being. The American Journal of Clinical Nutrition, 26, pp 211-218. The study began with subjects who were all treated for obesity using the Simeons protocol, but half were treated with HCG and half with an identical appearing placebo. Subjects were to be given a daily injection six days per week for a total of 36 injections, unless they reached their goal weight before completing six weeks of treatment. In the control group (placebo), 65% completed at least 30 injections and lost a mean of about 11 lbs. In the study group (HCG), 85% completed at least 30 injections and lost a mean of about 20 lbs. Little or no hunger was reported by about 50% of the control group while about 80% of the HCG group reported little or no hunger.
U.S. Pat. Nos. 5,428,023 (Russell-Jones, et al.) and 5,807,832 (Russell-Jones, et al.) disclose an orally administered composition ('023) and a method of treating a patient using that composition ('832). The composition comprises a hormone (HCG) covalently linked to vitamin B12 or a B12 analog. The B12 carrier molecule is capable of binding an intrinsic factor for uptake within the small intestine. A linking agent links the hormone to B12 molecule through the carboxyl group of an acid-hydrolyzed propionamide side chain. The method simply entails providing the above composition to a patient for oral administration. The formulation and method of the '023 and '832 patents possess distinct drawbacks. For one, the patents chemically bind HCG to another molecule using a linking agent. This binding requires additional manufacturing steps increasing the cost of production while also increasing the chances of product contamination. Moreover, the HCG is physically modified which may adversely affect its efficacy. Additionally, these patents do not describe or suggest the use of other vitamins or dietary supplements for use with HCG in a low calorie diet.
U.S. Pat. No. 7,605,122 (Tuntland) and United States patent application 2009/0181883 (Tuntland), describe a sublingual composition comprising human chorionic gonadotropin maintained at pH 7-8 using a sodium bicarbonate buffer along with glycerin and ethanol. The composition was developed to be used in a very low calorie diet protocol. The composition may further contain an absorption rate enhancer such as mineral oil or corn oil. Patent '122 describes using diet suppressants and/or potassium supplements during the diet. However, the suppressants and potassium supplements do not satisfy the underlying condition which causes dieters to continue to feel hunger—namely lack of nutrients. The additives in the formulations posited by patent '122 merely mask the symptoms of hunger and do not provide the nutrients needed by the body—particularly when on a low calorie diet.
Therefore, it is clear that a long felt need exists for a formulation containing HCG for use in a low calorie diet which satisfies a dieter's hunger response. If the protocol is used properly, the HCG should circulate enough calories, vitamins, and nutrients from fat breakdown to eliminate or greatly minimize hunger. Since Dr. Simeons did his work over 50 years ago, when eating habits were much different, a body's stored fat contained more nutrients than the fat stored in people today. Today's vegetables and fruits contain far fewer nutrients than decades ago. In the 1950's most nutrition was from fresh fruits and vegetables which were allowed to ripen naturally. This is not the case today where vegetables are picked before fully ripe. Also, many of the stored fat calories today come from prepared or junk foods, which have little or no nutritional value. Therefore, it is possible that the breakdown of fat today releases very low levels of vitamins and minerals. It has been found that approximately 20% of people on a low calorie diet with an HCG regimen still experience hunger. The current disclosure postulates that the hunger, while on HCG, is due to the brain perceiving a need for some vitamins and nutrients not found in our fat today. It has been observed that if certain vitamins and nutrients are added to the HCG, the percent of people who get hungry while on the protocol drops from about 20% to about 5%. The formulation of the present disclosure comprises HCG, B-complex vitamins, and select amino acids and other dietary supplements.